FDA.reportPublic FDA data

ADC

Primary DI
00634782603076
Brand
ADC
Company
AMERICAN DIAGNOSTIC CORP
Model
54205
Catalog number
54205
Device description
Specula, Reusable, 5.0mm, 500 pcs/cs
Published
2026-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EPYSpeculum, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EPYSpeculum, EntGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00634782603076PrimaryGS10
00634782101565Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00634782603076006347826030766347826030760634782603076
00634782101565006347821015656347821015650634782101565

GMDN Terms#

Term, Definition table
TermDefinition
Ear speculum, single-useA semi-rigid or rigid, plastic or metal tube that is cone-shaped (i.e., it tapers down from a standard instrument fitting size to a small opening) and is either hand-held and manually inserted, or fitted onto a compatible otoscope, and then inserted into the ear canal to create a channel for examination, suction, irrigation, or the insertion of another surgical device during an ear/nose/throat (ENT) procedure. It may be referred to as an ear cannula. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5Millimeter

Contacts#

Phone, Email table
PhoneEmail
1-800-232-2670info@adctoday.com

Regulatory Flags#

DUNS number
108999095
Device count
500
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00634782045708Proscope™665Y665Y2016-09-21
00634782098384Adscope®603-04W603-04W2026-03-30
00634782099473Prosphyg™760-11ABCAAQ760-11ABCAAQ2023-01-11
00634782102258Adscope®608CFST608CFST2026-06-02
00634782603045ADC54202542022026-03-31
00634782603052ADC54203542032026-03-31
00634782603069ADC54204542042026-03-31
00634782100209Adscope®608-12COP608-12COP2026-03-30
00634782100216Adscope®608-12G608-12G2026-03-30
00634782100223Adscope®608-12I608-12I2026-03-30
00634782100230Adscope®608-12ST608-12ST2026-03-30
00634782100247Adscope®608-12MBK608-12MBK2026-03-30
00634782100254Adscope®608-12RGBK608-12RGBK2026-03-30
00634782100261Adscope®608-12RGW608-12RGW2026-03-30
00634782100834Adscope®608-12BK608-12BK2026-03-30
00634782101190Adscope®608-01MBK608-01MBK2026-03-30
00634782101299Adsoft®602-078BK1Q602-078BK1Q2026-03-30
00634782101305Adsoft®602-078PR1Q602-078PR1Q2026-03-30
00634782101312Adsoft®602-078TQ1Q602-078TQ1Q2026-03-30
00634782101329Adsoft®602-078G1Q602-078G1Q2026-03-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04054462911752evonosevonos GmbH & Co. KGEPY2026-08-19
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04054462911776evonosevonos GmbH & Co. KGEPY2026-08-19
04054462911783evonosevonos GmbH & Co. KGEPY2026-08-19
04054462911806evonosevonos GmbH & Co. KGEPY2026-08-19
04054462911820evonosevonos GmbH & Co. KGEPY2026-08-19
04054462911837evonosevonos GmbH & Co. KGEPY2026-08-19
04054462911844evonosevonos GmbH & Co. KGEPY2026-08-19
04054462911851evonosevonos GmbH & Co. KGEPY2026-08-19
04054462911868evonosevonos GmbH & Co. KGEPY2026-08-19
04054462900879evonosevonos GmbH & Co. KGEPY2026-08-18
04054462900886evonosevonos GmbH & Co. KGEPY2026-08-18
04054462900893evonosevonos GmbH & Co. KGEPY2026-08-18
04054462900930evonosevonos GmbH & Co. KGEPY2026-08-18
04054462900961evonosevonos GmbH & Co. KGEPY2026-08-18
04054462900978evonosevonos GmbH & Co. KGEPY2026-08-18
04054462901081evonosevonos GmbH & Co. KGEPY2026-08-18
04054462901098evonosevonos GmbH & Co. KGEPY2026-08-18
04054462901104evonosevonos GmbH & Co. KGEPY2026-08-18
04054462901111evonosevonos GmbH & Co. KGEPY2026-08-18
04054462901128evonosevonos GmbH & Co. KGEPY2026-08-18
04054462901135evonosevonos GmbH & Co. KGEPY2026-08-18
04054462902323evonosevonos GmbH & Co. KGEPY2026-08-18
04054462902347evonosevonos GmbH & Co. KGEPY2026-08-18
04054462902354evonosevonos GmbH & Co. KGEPY2026-08-18
04054462902361evonosevonos GmbH & Co. KGEPY2026-08-18
04054462902392evonosevonos GmbH & Co. KGEPY2026-08-18
04054462902545evonosevonos GmbH & Co. KGEPY2026-08-18
04054462904815evonosevonos GmbH & Co. KGEPY2026-08-18